scholarly journals Results of the UK NEQAS for Molecular Genetics reference sample analysis

2018 ◽  
Vol 71 (11) ◽  
pp. 989-994 ◽  
Author(s):  
Susan D Richman ◽  
Jennifer Fairley ◽  
Jacqueline A Hall ◽  
Nakul Nataraj ◽  
Mrudul Bhide ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Genetics ◽  
External Quality Assessment ◽  
Single Gene ◽  
Reference Sample ◽  
Human Cell Line ◽  
External Quality ◽  
Gene Testing ◽  
Variant Frequency ◽  
Eqa Schemes

AimsIn addition to providing external quality assessment (EQA) schemes, United Kingdom National External Quality Assessment service (UK NEQAS) for Molecular Genetics also supports the education of laboratories. As an enhancement to the Molecular Pathology EQA scheme, a human cell-line reference sample, manufactured by Thermo Fisher Scientific (AcroMetrix), was provided for analysis. This contained many variants, present at frequencies between 1% and 17.9%.MethodsOne hundred and one laboratories submitted results, with a total of 2889 test results on 53 genes being reported. Known polymorphisms, 46/2889 (1.59%) results, were excluded. Variants detected in the seven most commonly reported (and clinically relevant) genes, KRAS, NRAS, BRAF, EGFR, PIK3CA, KIT and PDGFRA, are reported here, as these genes fall within the scope of UK NEQAS EQA schemes.ResultsNext generation sequencing (NGS) was the most commonly performed testing platform. There were between 5 and 27 validated variants in the seven genes reported here. Eight laboratories correctly reported all five NRAS variants, and two correctly reported all eight BRAF variants. The validated mean variant frequency was lower than that determined by participating laboratories, with single-gene testing methodologies showing less variation in estimated frequencies than NGS platforms. Laboratories were more likely to correctly identify clinically relevant variants.ConclusionsOver 100 laboratories took the opportunity to test the ‘educational reference sample’, showing a willingness to further validate their testing platforms. While it was encouraging to see that the most widely reported variants were those which should be included in routine testing panels, reporting of variants was potentially open to interpretation, thus clarity is still required on whether laboratories selectively reported variants, by either clinical relevance or variant frequency.

Molecular Genetics External Quality Assessment Pilot Scheme for KRAS Analysis in Metastatic Colorectal Cancer

2011 ◽  
Vol 15 (11) ◽  
pp. 777-783 ◽  
Author(s):  
Zandra C. Deans ◽  
Justyna Tull ◽  
Gemma Beighton ◽  
Stephen Abbs ◽  
David O. Robinson ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Quality Assessment ◽  
Metastatic Colorectal Cancer ◽  
Molecular Genetics ◽  
External Quality Assessment ◽  
External Quality ◽  
Pilot Scheme

scholarly journals External quality assessment for molecular diagnostic laboratories in Belgium: Can we improve it?

2019 ◽  
Vol 25 (1) ◽  
pp. 39-49
Author(s):  
Kelly Dufraing ◽  
Els Lierman ◽  
Anne Vankeerberghen ◽  
Sabine Franke ◽  
Els Dequeker
Keyword(s):  
Quality Assessment ◽  
Performance Monitoring ◽  
External Quality Assessment ◽  
Molecular Diagnostic ◽  
Real Patient ◽  
External Quality ◽  
Molecular Tests ◽  
Clinical Biology ◽  
Eqa Schemes ◽  
Selection Of

AbstractExternal quality assessment (EQA) is an essential part of performance monitoring for molecular laboratories. At the moment, a national law regulates participation in EQA schemes for clinical biology and pathology in Belgium. This study aimed (1) to get insights on how laboratories organize their EQA participation, (2) to poll satisfaction with the current situation (selection of EQA programs in advance by a governmental body), (3) to provide guidance for choosing the most relevant EQA provider and (4) to propose a new model for national performance monitoring. A survey was sent to Belgian laboratories performing molecular tests in the field of microbiology, hematology and pathology with (1) general questions on how they select an EQA provider and (2) their satisfaction of each provider. In total, 25 molecular laboratories [microbiology (N = 13), hematology (N = 8) and pathology (N = 4)] from 14 different hospitals completed the survey regarding their EQA organization. All three laboratory groups indicated to prefer EQA schemes using real patient materials as well as those with varying targets and concentrations. For molecular microbiology and hematology, schemes with a syndromic approach are sought. Since annual participation in EQA becomes burdensome in most laboratories, this paper also offers a risk-based strategy for determining the participation frequency. Based on the needs of Belgian laboratories, three proposals were made: (1) for the proper selection of an EQA scheme, (2) for determining the minimal participation frequency and (3) for the national organization of EQA schemes.

Quality Assessment of Tumor Marker Determinations: A Proposal for a Supraregional Scheme

1994 ◽  
Vol 9 (1) ◽  
pp. 48-52
Author(s):  
A. Piffanelli ◽  
M. Giganti ◽  
P. Colamussi ◽  
C. Cittanti ◽  
D. Pelizzola ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Tumor Marker ◽  
Tumor Markers ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
External Quality ◽  
Realistic Information ◽  
Eqa Schemes

The use of tumor marker tests has increased progressively in the last decade concomitant with the advent of new monoclonal antibodies and their growing use in clinical oncology for various follow-up programs. External quality assessment (EQA) schemes widely adopted in clinical chemistry, have been extended in the last decade to immunoassays of hormones and tumor markers. EQA results can provide realistic information on the quality of the assays, performed under routine conditions. The goal of this article is to report the main results and discrepancies encountered so far in External Quality Assessment programs on tumor markers.

External quality assessment (EQA) for CoaguChek monitors

2010 ◽  
Vol 103 (05) ◽  
pp. 936-941 ◽  
Author(s):  
Joergen Jespersen ◽  
A. M. H. P. van den Besselaar ◽  
Felix van der Meer ◽  
Gualtiero Palareti ◽  
Armando Tripodi ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Point Of Care ◽  
Concerted Action ◽  
External Quality ◽  
Test Strips ◽  
Italian Studies ◽  
Large Numbers ◽  
Treatment Procedures ◽  
Eqa Schemes

SummaryAnticoagulant control facilities are being overwhelmed by requests for monitoring and large numbers of patients are not therefore receiving treatment. Procedures designed for point-of-care testing have therefore been developed, the most popular being the CoaguChek. The need for external quality assessment (EQA) of monitors used by patients in self-management has been stressed in a European Commission (EC) Directive. It would not however be feasible for all CoaguChek monitors to be enrolled in national or regional EQA schemes which take time to organise and analyse. The European Concerted Action on Anticoagulation (ECAA) has therefore evolved a simpler system. Its value has been assessed in collaboration with the European Concerted Action on Thrombosis (ECAT). 523 monitors were tested at nine clinics which asked patients to bring their CoaguChek instruments to be assessed with the ECAA/ECAT procedure based on a set of 5 plasma samples with certified international normalised ratios (INR). 15% or more deviation from the certified INR on a single certified plasma sample from the set was defined by the ECAA as the limit of acceptable performance. One hundred and six (20.3%) of the monitors tested showed significant deviation and higher than average incidence of significant INR deviations reported with one specific numbered lot of test strips. Recent ECAA/ECAT, Danish and Italian studies report regular EQA of CoaguChek monitors is essential. There is general agreement that this should be performed at reasonably frequent intervals, at six months or whenever there is a change of the manufacturer’s test strips.

Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data

2015 ◽  
Vol 53 (11) ◽  
Author(s):  
Gladys Matar ◽  
Bernard Poggi ◽  
Roland Meley ◽  
Chantal Bon ◽  
Laurence Chardon ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Peer Group ◽  
Estimation Methods ◽  
Internal Quality ◽  
Factor V ◽  
External Quality ◽  
Uncertainty In Measurement ◽  
Target Values ◽  
Eqa Schemes

AbstractInternational organizations require from medical laboratories a quantitative statement of the uncertainty in measurement (UM) to help interpret patient results. The French accreditation body (COFRAC) recommends an approach (SH GTA 14 IQC/EQA method) using both internal quality control (IQC) and external quality assessment (EQA) data. The aim of this work was to validate an alternative way to quantify UM using only EQA results without any need for IQC data. This simple and practical method, which has already been described as the long-term evaluation of the UM (LTUM), is based on linear regression between data obtained by participants in EQA schemes and target values. We used it for 43 routine analytes covering biochemistry, immunoassay, and hemostasis fields.Data from 50 laboratories participating in ProBioQual (PBQ) EQA schemes over 25 months were used to obtain estimates of the median and 90th percentile LTUM and to compare them to the usual analytical goals. Then, the two UM estimation methods were compared using data from 20 laboratories participating in both IQC and EQA schemes.Median LTUMs ranged from 2.9% (sodium) to 16.3% (bicarbonates) for biochemistry analytes, from 12.6% (prothrombin time) to 18.4% (factor V) for hemostasis analytes when using the mean of all participants, and were around 10% for immunoassays when using the peer-group mean. Median LTUMs were, in most cases, slightly lower than those obtained with the SH GTA 14 method, whatever the concentration level.LTUM is a simple and convenient method that gives UM estimates that are reliable and comparable to those of recommended methods. Therefore, proficiency testing (PT) organizers are allowed to provide participants with an additional UM estimate using only EQA data and which could be updated at the end of each survey.

External Quality Assessment in The Netherlands: time to introduce commutable survey specimens. Lessons from the Dutch “Calibration 2000” project

2005 ◽  
Vol 43 (3) ◽  
Author(s):  
Henk Baadenhuijsen ◽  
Aldy Kuypers ◽  
Cas Weykamp ◽  
Christa Cobbaert ◽  
Rob Jansen
Keyword(s):  
Reference Material ◽  
The Netherlands ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Accuracy Assessment ◽  
Reference Method ◽  
Field Method ◽  
External Quality ◽  
Wet Chemistry ◽  
Eqa Schemes

AbstractThe performance of suitable secondary reference material for the use of trueness control of six routinely measured clinical enzymes in the Dutch External Quality Assessment (EQA) scheme is described. The reference material of choice was selected using the split-patient-sample between-field method (twin study) design as described in an earlier study of the Calibration 2000 project in The Netherlands. This material, which was proven to be commutable for all wet chemistry systems, was implemented as the national enzyme calibrator. It consisted of a cryo-protected lyophilised serum with additions of recombinant human enzymes. Various batches of the frozen version of this material without cryo-protection additive, called native EQA samples, were used in the general EQA scheme for performance evaluation. The results of Calibration 2000 calibrated and non-Calibration 2000 calibrated laboratories were compared for both the regular (spiked with non-human enzymes) and native EQA samples in terms of precision and bias with established reference method values for the native samples. The regular samples showed mean between-laboratory CV ranges for all six enzymes involved (low–high) of 5.5–10.3% for the non-calibrated users vs. 4.6–10.8% for the calibrated users. For the native samples these respective ranges were 5.2–9.9% vs. 2.2–4.9%. Without exception, the group of Calibration 2000 calibrated users showed the lowest bias against the reference method values. Regular EQA samples (spiked with non-human enzymes) showed poorer performance than native samples and are not suitable for accuracy assessment purposes, the main aim of EQA schemes. Native samples that are commutable should be used for trueness control in current EQA schemes.

scholarly journals Feasibility for aggregation of commutable external quality assessment results to evaluate metrological traceability and agreement among results

2021 ◽  
Vol 59 (1) ◽  
pp. 117-125
Author(s):  
Eline A. E. van der Hagen ◽  
Cas Weykamp ◽  
Sverre Sandberg ◽  
Anne V. Stavelin ◽  
Finlay MacKenzie ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Metrological Traceability ◽  
Relative Difference ◽  
Global Scale ◽  
External Quality ◽  
Aggregated Data ◽  
Target Value ◽  
Reference Target ◽  
Eqa Schemes

AbstractObjectivesExternal quality assessment (EQA) with commutable samples is used for assessing agreement of results for patients’ samples. We investigated the feasibility to aggregate results from four different EQA schemes to determine the bias between different measurement procedures and a reference target value.MethodsWe aggregated EQA results for creatinine from programs that used commutable EQA material by calculating the relative difference between individual participant results and the reference target value for each sample. The means and standard errors of the means were calculated for the relative differences. Results were partitioned by methods, manufacturers and instrument platforms to evaluate the biases for the measurement procedures.ResultsData aggregated for enzymatic methods had biases that varied from −8.2 to 3.8% among seven instrument platforms for creatinine at normal concentrations (61–85 μmol/L). EQA schemes differed in the evidence provided about the commutability of their samples, and in the amount of detail collected from participants regarding the measurement procedures which limited the ability to sub-divide aggregated data by instrument platforms and models.ConclusionsEQA data could be aggregated from four different programs using different commutable samples to determine bias among different measurement procedures. Criteria for commutability for EQA samples as well as standardization of reporting the measurement methods, reagents, instrument platforms and models used by participants are needed to improve the ability to aggregate the results for optimal assessment of performance of measurement procedures. Aggregating data from a larger number of EQA schemes is feasible to assess trueness on a global scale.

scholarly journals Mapping the coverage, availability and uptake of External Quality Assessment programmes across One Health sectors in Asia

2021 ◽  
Author(s):  
Ondari D Mogeni ◽  
Freshwork Ayalew Abegaz ◽  
Jong-Hoon Kim ◽  
Hea Sun Joh ◽  
Vicky Gaedt Kastbjerg ◽  
...  
Keyword(s):  
Quality Assessment ◽  
One Health ◽  
External Quality Assessment ◽  
External Quality ◽  
Laboratory Surveillance ◽  
Readiness Level ◽  
Support Mechanisms ◽  
Eqa Schemes

Abstract Introduction Establishing effective external quality assessment (EQA) programmes is an important element in ensuring the quality of, and building capacity for, antimicrobial resistance (AMR) laboratory surveillance. Objectives To understand the current coverage of, and challenges to participation in, EQAs in National Reference Laboratories (NRLs) across One Health (OH) sectors in Asia. Methods Current EQA coverage was evaluated through desktop review, online surveys and interviews of both EQA participants and providers. EQA coverage was mapped and summarized by laboratory type and ‘readiness’ level and identified challenges evaluated qualitatively. Results Of the 31 identified NRLs [16 Human Health (HH) and 15 Animal/Food Safety laboratories (A/FS)], 14 HH and 7 A/FS laboratories currently participated in international EQA schemes and several participated in two or more different schemes. Seven laboratories were currently not participating in any EQA scheme and two of these (one HH and one A/FS) do not currently perform microbiology; six HH NRLs provided national EQAs. Of the eight surveyed international EQA providers, three were based in Asia and all offered varying programmes in terms of pathogens, frequency and support mechanisms for reporting and follow-up. Only one provider currently served laboratories across all OH sectors. Conclusions The current coverage of EQA programmes for AMR in Asia was heterogeneous across countries but especially across OH sectors. This updated overview of the coverage and challenges associated with participation in, and provision of, EQAs for AMR suggest the benefit and relevance of introducing one comprehensive and high-quality EQA programme across OH sectors in Asia.

scholarly journals Frequency of Participation to External Quality Assessment Programs Focused on Rare Diseases: Belgian Guidelines for Human Genetics Centers. (Preprint)

2021 ◽  
Author(s):  
Joséphine Lantoine ◽  
Anne Brysse ◽  
Vinciane Dideberg ◽  
Kathleen Claes ◽  
Sofie Symoens ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Rare Diseases ◽  
Human Genetics ◽  
External Quality Assessment ◽  
Accreditation Body ◽  
External Quality ◽  
Quality Controls ◽  
Medical Centers ◽  
National Public Health ◽  
Eqa Schemes

BACKGROUND The participation to quality controls, also called External Quality Assessment (EQA) schemes, is required for the ISO15189 accreditation of the medical centers of human genetics. However, directives on the minimal frequency of participation to genetic quality controls schemes are lacking or too heterogeneous, with a possible impact on healthcare quality. OBJECTIVE The aim of this project is to develop Belgian guidelines on the frequency of participation to quality controls for genetic testing in the context of rare diseases. METHODS A group of experts has analyzed 90 EQA schemes offered by accredited providers and focused on analyses used for the diagnosis of rare diseases. On that basis, the experts developed practical recommendations about the minimal frequencies of participation of the medical centers of human genetics to quality controls and how to deal with poor performances and change management. These guidelines were submitted to the Belgian Accreditation Body and then reviewed and approved by the Belgian College of Human Genetics and Rare Diseases and by the National Institute for Health and Disability Insurance. RESULTS The guidelines offer a decisional algorithm for the minimal frequency of participation to human genetics EQA schemes. This algorithm has been developed taking into account the scopes of the EQA schemes, the levels of experience and the annual volumes of the center of human genetics in the performance of the tests considered. They include 3 key principles : (i) the recommended annual assessment of all genetic techniques and technological platforms, if possible through EQAs covering the technique, genotyping and clinical interpretation, (ii) the triennial assessment of the genotyping and interpretation of specific germline mutations and pharmacogenomics analyses, (iii) the documentation of actions undertaken in the case of poor performances and the participation to a quality control the following year. The use of a Bayesian statistical model has been proposed to help the centers of human genetics to determine the theoretical number of tests that should be annually performed in order to achieve a certain threshold of performance (e.g. maximal error rate of 1%). Besides, the guidelines insist on the role and responsibility of the national public health authorities in the follow-up of the quality of analyses performed by the medical centers of human genetics, and demonstrate the cost-effectiveness of the rationalization of the frequency of participation to these quality controls. CONCLUSIONS These guidelines have been developed based on the analysis of a large panel of EQA schemes and data collected from the Belgian Medical Centers of Human Genetics. They are totally applicable to other countries and will facilitate and improve the quality management and financing systems of the medical centers of human genetics. CLINICALTRIAL not applicable

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